Moica Sanchez

***** ** **** **

Opa-locka, Florida

ac3de3@r.postjobfree.com

Summary

Motivated Lead CRC with solid experience managing all levels of large scale projects, including budgeting and administration, with 6 years of experience. Following ICH/GCP guidelines, SOP's. Possesses the ability to maintain a problem-solving attitude, known for paying attention to detail. Experienced with strong leadership and relationship-building skills. Meticulous and excellent at juggling multiple tasks and also working under pressure. Education

Pedro Veliz

Bachelor of Science: Healthcare Nursing - Havana, Cuba Graduated June 2002

Continuing education in healthcare Coursework in Speech and Communication, Sociology and Psychology Coursework in Professional Prospecting Skills. Coursework includes: Sociology and Psychology

Manuel Fajardo School of Medicine

ICU Training - Havana, Cuba

Graduated September 2004

The scope of the roles and responsibilities of ICU nurses include but no limited to close monitoring of patients' vital signs every 15 or 30 minutes. ICU skills must be mechanically and technically adept in operating life support and cardiac monitoring systems. Also need to administer medications through intravenous line or injections.

Compu-Med Vocational Career

Clinical Registered Medical Assistant - Miami, Florida Graduated February 2010

Obtain National License and maintain up to date.

Florida National University

Bachelor in Science of Psychology - Miami, Florida Enrolled

Emphasis in Science of Psychology and the knowledge of the necessary skills to become competent in counseling psychology through academic and experimental learning. Dade Medical School

Nursing - Miami, Florida

Deferred

Employment History

Biotech Pharmaceutical Group

Miami, Florida

Lead Clinical Research Coordinator

August 2015 – Present

• Prepares ICF and/or consenting subject with an extensive knowledge of Inform Consent Process

• Responsible for eCRF entry and Regulatory Documents completion

• Reviews all documents for completeness

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• Ensures accuracy and compliance with study protocols

• Creates source documentation for trials

• Implements training programs for CRCs and other clinical staff with topics that include principles and practices of project management

• Reports AE's/SAE's and the importance of pharmacovigilance control

• Oversees storage of documents as appropriate in temporary and long-term storage in accordance with standard procedures

• Responsible for tracking subject recruitment and enrollment

• Responsible for study closeout

• Coordinates of data query resolution and database lock to meet study timelines

• Develops and maintains patient database, investigational logs and study regulatory documents

• Serves as primary contact with the sponsor regarding overall study conduct timelines

• Participating Clinical Study Protocols:

o 2016-Present, A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Fluticasone Propionate Multi-dose Dry Powder Inhaler Compared with Fluticasone in pediatric patients

o 2016-Present, A Randomized, Single-Blind, Parallel-Group, Placebo-Controlled, Multi-dose Study Comparing the Therapeutic Equivalence of a 3M Inhaler and a Symbicort® In Adult subject with asthma

o 2016 – 2017, abbvie: A phase II Uterine Fibroids Study to evaluate the safety and efficacy of XXXX in premenopausal women with heavy menstrual bleeding associated with uterine fibroids

o 2015- 2016, INC Research: Complex Pain Phase II/III a Randomized, double-blind trial investigating the efficacy and safety of intravenous XXX in subjects with complex pain syndrome type I (CRPS-I)

o 2016-2017, A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort in pediatrics patients

o 2016-2017, An Open-Label, Long-Term Safety and Tolerability Study of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation (IBS-C) Precision Research Organization

Miami Lakes, Florida

Lead Clinical Research Coordinator

January 2013 – August 2015

• Assists PI in accordance with Good Clinical Practice (GCP)

• Follows SOPs and principles set forth in the CRF and ICH guidelines

• Oversees the ordering and shipment of study drug supply

• Coordinates study start-up activities with the sponsor

• Prepares, submits and maintains Institutional Review Board (IRB) and / or other regulatory documents

• Conducts quality control checks of the work of self and others to ensure that work quality is acceptable

• Meets protocol standards and in compliant with regulatory requirements

• Completes and/ or maintain site documentation including but not limited to case report forms (CRF)

• Participating Study Protocols:

o 2013-2014 Boehringer Ingelheim: Phase IV T2DM, A multicenter, international, randomized, parallel group, double blind, placebo-controlled Cardiovascular Safety & Renal Microvascular outcome with XXX, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. CARMELINA o 2013 –2014, Novartis: Phase III COPD T2DM, A multi-center, randomized, double- blind, 52-week study to assess the safety of XXXX compared to XXXX in patients with Chronic Obstructive Pulmonary Disease (COPD) who have moderate to severe airflow limitation

o 2013 –2014 Present Novartis: Phase III Rheumatoid Arthritis, A three year extension study to evaluate the long term efficacy, safety and tolerability of XXXXX in subjects with active rheumatoid arthritis

o 2013 –2014, Novartis: Phase III COPD T2DM, A multi-center, randomized, double- blind, 52-week study to assess the safety of XXXX compared to XXXX in patients with Chronic Obstructive Pulmonary Disease (COPD) who have moderate to severe airflow limitation

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o 2014- 2015, TEVA/Cephalon: Narcolepsy Phase 1A Randomized, Open-Label Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Single and Multiple Doses of XXXX (50, 100, and 150 mg/day) in Children and Adolescents with Excessive Sleepiness Associated With Narcolepsy

o 2014- 2015, Novo Nordisk: Phase III T2DM Efficacy and safety of XXX once-weekly versus insulin glargine once daily as add-on to metformin without XXX in insulin-naïve subjects with type 2 diabetes

Elite Research Institute

Miami, Florida

Clinical Research Coordinator

January 2010 – June 2013

• Assists PI in accordance with Good Clinical Practice (GCP)

• Follows SOPs and principles set forth in the CRF and ICH guidelines

• Ensures all key personnel involved in research has completed the required training

• Develops and maintains patient database, investigational logs and study regulatory documents

• Serves as primary contact with the sponsor regarding overall study conduct timelines Therapeutic Experience

• Respiratory

• Endocrinology

• Women's Health

• Cardiovascular

• Oncology

• Immunodeficiency

• GI

• Pediatrics

Professional Skills

• iMedidata Rave

• Data management

• Clinical Databases based on Oracle

• Microsoft Office (Word, Excel, PowerPoint, Access, Internet Explorer, SharePoint)

• CTMS

• iMED Database

• Adobe Acrobat 5.0-11.0

Languages

• Spanish, Native

• English, Fluent

References

Available upon request

Contact this candidate